Optimizing Fail-Safe Use of Complex Medical Devices.

As part of its comprehensive journey toward high reliability, Memorial Hermann Health System has implemented multiple patient safety initiatives. An instance of actual patient harm due to staff unfamiliarity with a medical device triggered a project to ensure the competence of clinical staff in the operation of all approved new and updated medical devices. Medical devices are classified by level of risk to patients if caregivers are not reliably educated. Educational rigor, with tracking and accountability management, is then scaled to that risk assessment. The objective is to decrease safety events related to use of medical devices by ensuring failure-free medical device use. An interdisciplinary team was created to design a "fail-safe" process to analyze and scale training for use of medical devices, with a risk assessment tool predicting the potential severity and frequency of harm to patients. The fail-safe process became an approved procedure and practice standard at the institution.